Plain English Summary

Trial website

Contact information

Type

Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Telemonitoring in heart failure: a multicentre randomised trial

Acronym

Study hypothesis

A heart failure clinic using telemonitoring of weight, blood pressure, heart rate and an automatic symptoms questionnaire allows to reduce the hospitalisation frequency, its duration and mortality. It also increases quality of life and reduces the number of unplanned consultations with the first and second line.

Study design

Primary study design

Secondary study design

Trial setting

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Congestive heart failure

Intervention

Telemonitoring will consist of daily patient self-measurements of body weight, blood pressure and heart rate with devices that allow automatic transfer of registered data to a web-site. This web-site will trigger E-mail alerts to care providers if data are out of limits, or if data have not been received. The tele-monitoring approach will be assisted by a central call centre, allowed to contact patients if technical problems with devices are suspected. The patients will also be called by an automatic telephone system to answer a short symptom questionnaire once every week.

The total follow-up in control patients, and intervention for other patients, is 6 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

1. Number and duration of hospitalisation after the start of the study2. Number of unplanned consultations with the heart failure team and GP3. Number of phone calls (and amount of time spent) between the HF nurse and the patient4. Quality of life (Minnesota Living with Heart Failure Questionnaire)5. Mortality rate6. Number of medication changes7. Number of changes in alert limits

Secondary outcome measures

Overall trial start date

01/04/2008

Overall trial end date

01/06/2010

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients hospitalised for decompensated heart failure, necessitating intravenous (IV) diuretics or augmentation of oral (PO) diuretic, IV inotropic or IV vasodilator. Patients should be stabilised with treatment including angiotensin converting enzyme (ACE) inhibitors (or angiotensin II receptor antagonists [AIIA]), betablockers and diuretics at discharge.2. Patients should be capable of understanding the aims of the study and to use the telemonitoring system3. Aged between 50 and 85 years, either sex